Polymerizable isolation barriers with enhanced tissue adherence and methods for forming and using such barriers

ABSTRACT

The polymerizable dental isolation barrier has a monomer and an initiator. The barrier composition has at least one additive including a polymer strength reducer, a wet tissue adherence accentuator, and a reflective material The polymer strength reducer is an organic compound that prevents complete polymerization. The tissue adherence accentuator enables the barrier to adhere to a dental substrate ever after polymerization. The reflective material lowers the reaction rate and lowers the production of excess heat to reduce patient discomfort and to avoid tissue damage.

RELATED APPLICATIONSS

The present application is a divisional of Ser. No. 08/802,674, filed onFeb. 19, 1997 for POLYMERIZABLE ISOLATION BARRIERS AND METHODS FORFORMING AND USING SUCH BARRIERS, by the following inventors: Steven D.Jensen and Dan E. Fischer.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

The present invention relates to compositions and methods for isolatingdental tissue for treatment thereupon. In particular, the presentinvention relates to polymerizable isolation barrier compositions andmethods of using the same for isolating tooth surfaces. Thepolymerizable barrier compositions of the present invention may includeconstituents that enable the compositions to adhere to wet, dry, soft orhard oral tissues; to minimize injury risks due to heat frompolymerization and/or light radiant energy from subsequent treatment(s);and that enable the barriers to be easily removed.

2. The Relevant Technology

Several dental procedures exist that use treatment compositions in themouth that could be harmful and damaging to soft tissue. Harmfultreatment compositions must be kept away from soft tissue such as thegums during sue h treatment procedures. There are other dentalprocedures that require a substantially dry tooth that must bemaintained in a dry condition during a lengthy dental procedure to avoiddamage.

In general, contact between a treatment composition and the cheeks andtongue of a patient can be minimized through the use of cotton rolls,absorbent isolators, rubber dams, rubber dam caulking or otherconventional isolation techniques. The gums, adjacent denting andsurrounding sulcular tissues however arc harder to protect from thetreatment composition(s) due to their close proximity to the surfacesbeing treated and because the treatment composition is sometimes afreely flowable aqueous solution.

Although it is possible to incorporate some treatment compositionswithin a gel in order to inhibit the unwanted flow of the treatmentcomposition from the desired treatment area, they generally must have alow enough viscosity to flow into the tiny crevices and otherirregularities of the surface of the tooth being treated. Hence, it isgenerally impractical to have a treatment composition that is so viscousthat it is not at least partially flowable.

In addition to adjusting the flow characteristics, the concentration ofthe treatment composition can be modified to reduce the damage caused byinadvertent contact with surrounding sulcus and gum tissues. However,significantly reducing the concentration of a treatment composition alsoreduces its ability to treat the tooth, thereby increasing the time inwhich the treatment composition must remain In contact with the surfacebeing treated. In general, treatment compositions strong enough toadequately treat teeth may also damage and irritate surrounding soft gumtissues.

Rubber dam technology was developed as a means of isolating a tooth fortreatment and also for protecting the vulnerable soft tissue. FIG. 1illustrates the installation of a rubber dam 10. It can be seen thatrubber dam 10 has been placed over the teeth 14 and then rubber dam 10is fitted with a dental instrument 16 by pushing rubber dam 10 up to thegum line 12. This procedure must be carried out on each tooth.

Rubber dams, however, have several disadvantages. One disadvantage isthat rubber dams can be difficult to install. Rubber dams have ahole-punched perimeter shape that may or may not isolate soft tissuenext to the tooth because the tooth perimeter shape might haveconcavities. For example, where a tooth forms an unusual groove orconcavity, a hole-punched rubber dam may leave an exposed space throughwhich treatment compositions could leak that could harm soft tissue. Ifthe seal created by a rubber dam is faulty, soft tissue is exposed andlikely to be damaged by the treatment composition.

Another disadvantage to rubber dams is that they are prone to tearingonce placed over the tooth. If the rubber dam begins to tear in themiddle of a dental procedure, the procedure must be aborted and a newrubber dam installed. This is time consuming and the new rubber dam maylikewise tear at or near the same point of the treatment that theoriginal rubber dam began to tear. Additionally, when the rubber damtears during a procedure, it may be too late to prevent the treatmentcompositions from contacting the soft tissue and therefore too late toprevent soft tissue damage.

Another disadvantage to rubber dams is that they often cause patientdiscomfort. FIG. 2 illustrates installation of a rubber dam 10 withrubber dam clamps 22 and a frame 20 that covers the labia 24 and thetongue 26. When, for example, a labial surface of a tooth is the onlysurface that needs to be isolated, rubber dam 10 may cover more than theteeth.

Additionally, where an intense dental curing or laser light is beingused, heat buildup incidental to use of the light may cause patientdiscomfort due to heating of the rubber dam. Intense heating of the softtissue will necessitate intermittent use of the dental light a practicethat slows the clinician in his procedure.

One attempt to overcome the problems associated with rubber damsprovided a blue flowable resin that can be applied onto a dentalsubstrate and then be polymerized. Due to the color of the resin, itabsorbs light energy which resulting increases the risk of injury tosoft tissue in contact with the resin. Additionally, the resin ishydrophobic which significantly hinders its ability to adhere well todental tissues. Another significant problem with this resin is that itis too strong and consequently the polymerized resin is very difficultto remove. Difficulties related to excessive strength are onlyexacerbated by application of the resin onto dental surfaces such aswide open embrasures and undercuts. For example, open embrasures aretypically filled from both sides which results in the embrasures beingcompletely filled and solidly anchored. After polymerization, it is verydifficult to remove the resin and may require prying instruments or evenhigh speed drills. Similarly, undercuts present a problem when resinbecomes lodged into the openings or crevices and it may their necessarybe to remove the resin with dental tools which the require the use ofsome force such as prying instruments or excavating tools.

In light of the foregoing, it would be a significant advancement in theart to provide isolation barrier compositions and methods for protectingsulcular and gum tissues surrounding a tooth being treated from intensecumulative heat buildup in order to avoid patient discomfort and toexpedite dental treatments that use a curing or laser light

It would also be a significant advancement in the art to provideisolation barrier compositions and methods for protecting sulcular andgum tissues surrounding a tooth being treated that can be easily removedfollowing a dental procedure.

It would be a further advancement in the art to provide compositions andmethods that result in a quickly and easily applied barrier to maintaina treatment composition within the area of the tooth that is desired tobe treated.

Another advancement in the art would be to provide compositions for anisolation barrier material that, upon application to the dentalsubstrate and polymerization, are sufficiently weakened to facilitateits removal in discrete, approximately tooth-sized segments or largerwith a tweezers-like instrument from the dental substrate after use in adental procedure.

Another advancement in the art would be to provide compositions for anisolation barrier material that, upon application to the dentalsubstrate and polymerization, are resistant to deformation at theexternal surface of the barrier due to incidental touching but thatremain adherent to the dental substrate at the internal surface of thebarrier.

Another advancement in the art would be to provide a composition for anisolation barrier material that, upon application to the dentalsubstrate and polymerization, is of a generally small size and conduciveto a customized fit that avoids inducing patient discomfort.

Such polymerizable isolation barrier compositions and methods for usingthem are disclosed and claimed herein.

SUMMARY AND OBJECTS OF THE INVENTION

It is an object of the present invention to provide isolation barriercompositions and methods for protecting tissues surrounding a tooth andthat can be easily removed following a dental procedure.

It is a further object of the present invention to provide compositionsand methods that result in a quickly and easily applied barrier tomaintain treatment composition within the area of the tooth that isdesired to be treated.

Another object of the present invention is to provide compositions foran isolation barrier material that, upon application to the dentalsubstrate and polymerization, are sufficiently weakened to facilitatetheir removal in discrete, approximately tooth-sized segments or largerwith a tweezers-like instrument from the dental substrate after use in adental procedure and even easily break lose from undercuts or whenlocated between a large embrasure.

Another object of the present invention is to provide compositions foran isolation barrier material that, upon application to the dentalsubstrate and polymerization, are resistant to deformation at theexternal surface of the barrier due to incidental touching but thatremain adherent to the dental substrate at the internal surface of thebarrier.

Another object of the present invention is to provide compositions foran isolation barrier material that, upon application to the dentalsubstrate and polymerization, are configured to decrease thepolymerization reaction rate and thereby reduce patient discomfort andthermal tissue damage due to substantial heat production duringpolymerization.

Various compounds were found to assist in formulation of a polymerizableisolation barrier for several types of dental procedures. Thesecompounds are advantageously added together in whole or in partialcombinations to achieve specific advantages over the prior art.

The isolation barrier of the present invention is made polymerizable byproviding at least one monomer in the inventive composition. The monomeris preferably of substantially low toxicity to humans. The monomer canbe a single monomer or a selection of monomers depending upon thespecific application.

One advantage to using preferred monomers is that a cohesive isolationbarrier may be fashioned in the mouth and the need for the traditionalrubber dam is eliminated. As such, the clinician is not concerned withpunching, fitting, repairing, and sealing a rubber dam, rather, with theinventive isolation barrier, the polymerizable isolation barrier isapplied to seal soft tissue and isolate hard tissue for a desiredprocedure, and is removed in integral, tooth-sized segments or largerafter completion of the dental procedure.

A curing agent is provided to induce the monomer to cross link uponexposure to adequate light radiant energy. The curing agent ispreferably of substantially low toxicity to humans. Curing agents mayalso be selected to be complementary to other ingredients for a selecteddental procedure. Optional additives are preferred in formulating curingagents depending upon the specific application of the polymerizableisolation barrier.

During polymerization, there are several variables to monitor. Heat isusually generated during polymerization. A significant increase intemperature during polymerization can cause discomfort to the patient orcan be sufficient to also cause burning of oral tissue. To control heatproduction, an organic compound is preferred that will provide acompositional quality of preventing complete polymerization of theisolation barrier material, thus, the total exothermic heat potentialfor a given amount of monomer will be reduced during polymerization. Inaddition to preventing unwanted excess heat of reaction, it was foundthat certain organic compounds cause the isolation barrier material tobecome significantly weakened or brittle compared to a barrier materialwithout such organic compounds. A weakened isolation barrier has theadvantage of easy removal after completion of the dental procedure. Theclinician can take hold of the polymerized isolation barrier with aninstrument like tweezers and remove it in discrete segments that areabout the size of a tooth or larger. The advantage is that, where aprincipally hydrophobic isolation barrier is required for a given dentalprocedure, removal after the procedure takes only one removal step or atmost a few removal steps and if any smaller portions crumble, they areeasily rinsed away after being dislodged.

During polymerization, it would be advantageous that the interiorsurface of the inventive isolation barrier will slightly adhere to wetor dry, hard or soft tissue (henceforth "tissue"). The tern "slightlyadhere," refers to adherence of the isolation barrier to tissue that,upon removal, will not substantially remove epithelial tissue of thegums in a way that causes discomfort to the dental patient. As a featureof the present invention, it was found that when an adherenceaccentuator is added, the isolation barrier material will adhere betterto tissue before, during, and after polymerization.

When the barrier is utilized in a dental procedure such as bleachingwith a peroxide composition that would harm tissue, a preferredprocedure is to apply the isolation barrier composition and begin topolymerize with a dental curing light. Later, as the dental curing lightis also used to activate the peroxide bleaching composition,polymerization may continue. With preferred tissue adherenceaccentuators, the isolation barrier composition continues to adhere towetted tissue even when the monomer becomes substantially polymerized.An advantage of this feature of the invention is that a substantiallyconformal isolation barrier can be laid up against the tooth to isolateit and the barrier will adhere adequately to tissue during a time periodfor standard isolation treatment procedures.

Another method of lowering harmful amounts of excess heat releasedduring polymerization or during a subsequent dental procedure is toreflect some of the light radiant energy of the dental light away fromthe isolation barrier composition. Dental curing lights and lasertreatment lights typically come with only intense light radiationsettings. These intense light radiation settings are very desirable insome dental applications such as in peroxide teeth bleaching. It wasfound that the addition of reflective materials reflects some portion ofthe dental light thereby reducing heating of the isolation barrierduring a dental procedure and minimizing harmful conductive or radiantheat transfer to gums or other soft tissues. Thus, the compositionabsorbs less light radiant energy, the isolation barrier is lessenergized than would be otherwise, and the underlying gum tissue is notsubjected to undue heating during a dental procedure.

The inventive polymerizable isolation barrier material is preferablymade in a paste or gel form that is rheologically able to be expressedfrom a dental syringe. The components of the isolation barrier materialform either an emulsion or a solution depending upon selection of apreferred application.

The inventive polymerizable isolation barrier material is alsopreferably made in a roll or tape form of a curable putty. The roll ortape is unrolled, cut into a strip to a desired length, placed onto thegums, pressed substantially conformably into place, for example withfinger pressure, carved to isolate hard tissue, and then cured withlight radiant energy. The components of this isolation barrier materialform either an emulsion, a dispersion, a suspension, a solution, etc.depending upon selection of a preferred application.

These and other objects and features of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that the manner in which the above-recited and other advantagesof the invention are obtained, a more particular description of theinvention briefly described above will be rendered by reference tospecific embodiments thereof which are illustrated in the appendeddrawings. Understanding that these drawings depict only typicalembodiments of the invention and are not therefore to be considered tobe limiting of its scope, the invention will be described and explainedwith additional specificity and detail through the use of theaccompanying drawings in which:

FIG. 1 is a prior art elevational front view of teeth and gums that arebeing isolated and protected, respectively in preparation for a dentalprocedure that requires isolating the teeth for the procedure whileprotecting tissue including gums from the treatment composition, and inwhich it can be seen that a rubber dam is the medium to protect thetissue by which it is being fitted to the tooth-gum juncture by a dentalinstrument.

FIG. 2 is a prior art elevational front view of a patient with a rubberdam installed that includes a rubber dam frame and rubber dam clampsthat are secured to a large molar.

FIG. 3 is an elevational front view of a patient during installation ofthe inventive isolation barrier, in which the isolation barrier is beingexpressed through a syringe substantially conformable to the tooth-guminterface in preparation for polymerization by light radiant energy.

FIG. 4 is an elevational front view of a patient during removal of theinventive isolation barrier after polymerization, in which the isolationbarrier is being removed in a discrete segment with a tweezers-likeinstrument.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The polymerizable isolation barriers are useful for many types of dentalprocedures. The polymerizable isolation barrier compositions comprise atleast a monomer, a curing agent, and at least one other constituent. Theother constituents include polymerization strength reducers, tissueadherence accentuators and reflective materials. The compositions can beutilized with any light radiant energy which includes the fullelectromagnetic spectrum.

The polymerization strength reducers prevent the polymerizablecomposition from becoming difficult to remove. The tissue adherenceaccentuators ensure adequate adhesion to any dental substrate. Thereflective materials reflect light radiant energy. By reflecting lightradiant energy, the heat produced by polymerization is maintained to adesirable level and harmful conductive or radiant heat transferred togums or other soft tissues during a subsequent procedure is minimized.The combinations achieve specific advantages over the prior art.

A. Monomers.

The isolation barrier of the present invention is made polymerizable byproviding at least one monomer in the inventive composition. The monomeris preferably of substantially low toxicity to humans. The monomer canbe a single monomer or a selection of monomers depending upon thespecific application. For example, when performing a dental procedureinvolving acid etching, it is preferred to select a monomer orcombination thereof that, when polymerized, is resistant to acid, thus,the isolation barrier will hold a seal against tissue to protect it fromthe acid.

One advantage to using the polymerizable isolation barrier is that acohesive isolation barrier may be fashioned in situ in the mouth and theneed for the traditional rubber dam is eliminated. As such, theclinician is not concerned with punching, fitting, repairing, andsealing a rubber dam, rather, with the inventive isolation barrier, theisolation barrier is applied to seal tissue and isolate hard tissue fora desired procedure, is polymerized, and is removed in integraltooth-sized segments or larger after completion of the dental procedure.The clinician can remove the barrier by any means. However thecomposition enables a clinician to take hold of the polymerizedisolation barrier by hand and easily remove it as an integral unit or indiscrete segments, or a dental instrument like tweezers can be used foreasy removal.

The size of the discrete segments is generally about one-half the areathat the isolation barrier is isolating. For example, as illustrated inFIG. 3 if the clinician were to stop applying the inventive isolationbarrier at the, point illustrated therein, the size of the discretesegments would generally be about one-half the length as applied.Another example is when the whole arch is being isolated, it ispreferable that the discrete segments are at least about one-fourth thelength of the arch, more preferably at least about one-half the lengthof the arch, and most preferably the isolation barrier will be removedas an integral unit.

Examples of suitable monomers include alkylmethacrylates.alkylhydroxymethacrylates, and alkylaminometliacrylates and derivativesthereof. The alkylmethacrylates include triethylene glycoldiinethacrylate, polyethylene glycol (PEG) dimethacrylate (all molecularweights), butane di-ol dimethacrylate, and equivalents. Thealkylhydroxymethacrylates include 2-hydroxy ethyl methacrylate, glyceroldimethacrylate bis-GMA, and equivalents. The alkylaminomethacrylatesinclude urethane dimethacrylate and equivalents. The monomers of thepresent invention are provided in a concentration range from about 50 toabout 99 percent, preferably from about 60 to about 95 percent, and mostpreferably from about 70 to about 90 percent by weight of thecomposition. The preferred methacrylates include alkylmethacrylates. Themore preferred methacrylale is triethylene glycol dimethacrylate. Inaddition to the above methacrylates, other monomers are within thecontemplation of the present invention and can be found by routineexperimentation by reading the disclosure and practicing the invention.

B. Curing Agents

Curing agents were found to be useful, and depending upon the specificdenial procedure, were preferred with or without certain organic amineadditives.

A curing agent is provided to induce the mnonomer to cross link uponexposure to adequate light radiant energy. The curing agent ispreferably of substantially low toxicity to humans. Curing agents mayalso be selected to be complementary to other ingredients for a selecteddental procedure. Curing agents include photoinitiators and amineadditives as needed.

Examples of photoinitiators include camphorquinone; benzoin methylether; 2-hydroxy-2-methyl-1-phenyl-1-propanone; diphenyl2,4,6-trimethylbenzoyl phosphine oxide; benzoin ethyl ether;benzophenone; 9,10-anthraquinone, and equivalents.

Optional additives such as amine additives are preferred in formulatingcuring agents to assist the curing agents depending upon the specificapplication of the polymerinzble isolation barrier. Examples of amineadditives include dimethyl amino ethyl methacrylate; tri ethyl amine;2-dimethylamino ethanol; diethyl amino ethyl methacrylate; trihexylamine: N, N-dimethyl-p-toluidine; N-methylethanolamines and equivalents.

The curing agents of the present invention are provided in aconcentration range from about 0.01 to about 2 percent, preferably fromabout 0.1 to about 1 percent, more preferably from about 0.2 to about0.8 percent, and most preferably about 0.3 percert by weight of thecomposition. The preferred curing agent includes2-hydroxy-2-methyl-1-phenyl-1-propanone and diphenyl2,4,6-trimethylbenzoyl phosphine oxide. In addition to the above curingagents, other curing agents are within the contemplation of the presentinvention and can be found by routine experimentation by reading thedisclosure and practicing the invention.

C. Polymerization Strength Reducers.

During polymerization, there are several variables to consider. Heat isusually generated during polymerization due to the exothermic nature ofpolymerization. A significant increase in temperature duringpolymerization can cause discomfort to the patient or can be sufficientto also cause burning.

An organic compound is preferred that has the capability tosubstantially decrease or minimize the degree of polymerization of theisolation barrier material compared to a barrier material without suchan organic compound. Thus, the total exothermic heat potential for agiven amount of monomer will be reduced during polymerization.

In addition to preventing unwanted excess heat of reaction, it was foundthat certain organic compounds cause the isolation barrier material tobecome weakened. A weakened isolation barrier has the advantage of easyremoval after completion of the dental procedure. The clinician can takehold of the polymerized isolation barrier by hand or with an instrumentlike tweezers and remove it in discrete segments or as integral unit.The sizes of the discrete segments is generally about one-half the areathat the isolation barrier is isolating. For example, when the wholearch is being isolated, it is preferable that the discrete segments areat least about one-fourth the length of the arch, more preferable atleast about one-half the length of the arch, and most preferably theisolation barrier will be removed as an integral unit. The advantage isthat, where a hydrophobic isolation barrier is required for a givendental procedure, removal after the procedure takes only one or a fewremoval steps and any small portions that may crumble are easily rinsedaway after being dislodged.

Examples of suitable polymerization strength reducers include oils suchas meal oils. Other suitable examples include alcohols such as cetylalcohol, steryl alcohol. derivatives thereof, and equivalents. Yet othersuitable examples include polyols such as polyethylene glycols,polypropylene glycols, propylene glycol, derivatives thereof, andequivalents. The polymerization strength reducers of the presentinvention are provided in a concentration range, when included, fromabout 1 to about 30 percent, preferably from about 5 to about 20percent, more preferably from about 10 to about 15 percent, and mostpreferably about 12 percent by weight of the composition. Of thepolymerization strength reducers, the preferred includes cetyl alcohol.

D. Tissue Adherence Accentuators.

During polymerization of the isolation barrier and during treatment, itis desirable that the isolation barrier adhere between an interiorsurface of the inventive isolation barrier and wetted tissue. As afeature of the present invention, it was found that when an adherenceaccentuator is added, the isolation barrier material will adhere betterto tissue before, during, and after polymerization. An inner surface ofthe isolation barrier is one that interfaces with the dental substrate.

When the isolation barrier is utilized as part of a dental procedureinvolving teeth bleaching with a peroxide composition that would harmtissue, it is preferable to apply the isolation barrier composition andbegin to polymerize with a dental light. After the barrier is positionedand polymerized, the dental light is used to activate the peroxidebleaching composition which also may cause continued polymerization ofthe isolation barrier. With preferred tissue adherence accentuators, theisolation barrier composition continues to gently adhere to wettedtissue even when the monomer becomes substantially polymerized. Anadvantage of this feature of the invention is that a substantiallyconformal isolation barrier can be laid up against the tooth to isolateit and it will adhere adequately to tissues during a time period forstandard isolation treatment procedures.

Examples of tissue adherence accentuators include gums such as xanthangum, guar gum, tragacanth gum, their derivatives, and equivalents. Otherexamples include cellulose materials such as ethyl cellulose,hydroxypropyl methyl cellulose, their derivatives, and equivalents. Yetother examples include polymers such as carboxy poly methylene,polysiloxanes, water-soluble polyethylene oxide polymers, derivativesand equivalents. The water-soluble polyethylene oxides preferably havemolecular weights of around 100,000 or more even up to several million.The preferred water-soluble polyethylene oxide polymer is sold asPolyox® by Union Carbide. Additionally, high molecular weight polyolscan function as tissue adherence accentuators such as polypropyleneglycols and polyethylene glycols having a molecular weight of at least600. The tissue adherence accentuators of the present invention, whenused, are supplied to the inventive composition in a concentration rangefrom about 0.01% to about 9%, preferably from about 0.03% to about 5%,more preferably from about 0.05% to about 3%, and mos. preferably about0.1% by weight of the composition. The preferred tissue adherenceaccentuator is xanthan gum.

E. Reflective Materials.

Another method of lowering harmful amounts of excess heat releasedduring polymerization is to reflect some of the light radiant energy ofthe dental light away from the isolation barrier composition. Dentalcuring lights and laser treatment lights typically come with onlyintense light radiation settings, which is desirable in certainapplications such as peroxide teeth bleaching. It was found that theaddition of reflective materials causes a portion of the dental light tobe reflected thereby reducing heating of the isolation barrier duringpolymerization, particularly when polymerized with a light at an intenselight radiation setting, and during a subsequent dental procedure suchas bleaching. Thus, the composition absorbs less light radiant energy,the isolation barrier is less energized than would be otherwise, theunderlying gum tissue is not subjected to undue heating during a dentalprocedure that uses a curing or laser light and light is even reflectedaway from the underlying gums or other protected tissue.

Examples of reflective materials include metals such as gold flake,aluminum flake, titanium flake, and equivalents. Other examples includemetal oxides such as aluminum oxide, titanium dioxide, precipitatedsilica, ceria, thoria and equivalents. Yet other examples include micasand equivalents. The reflective materials of the present invention, whenincluded, are provided in a concentration range from about 1 to about 50percent, preferably from about 2 to about 30 percent, more preferablyfrom about 3 to about 20 percent, and most preferably about 15 percent.The preferred reflective material comprises micas.

F. General Properties.

It is advantageous to combine various aspects of the present inventionfor preferred applications. For example, a peroxide gel may be thetreatment composition and light radiant energy will be used both duringpolymerization of the compositions of the present invention and laterduring peroxide bleaching material. In such a case, the clinician mayselect a composition that includes polymerization strength reducers,tissue adherence accentuators, and reflecting materials. Thus, such acomposition will achieve a weakened isolation barrier for easy removaland for resistance to incidental touching during the dental procedure,it will assure that the isolation barrier sufficiently remains in placeto adequately seal off the soft tissue while the bleachant is on thetooth, and reflects intense light energy during a treatment procedure toprotect the underlying gums from undue heating.

Alternatively, an application might be required where the tooth is to beisolated for dryness purposes. In such a case, the clinician may selecta composition that includes polymerization strength reducers and tissueadherence accentuators. Thus, such a composition will achieve a weakenedisolation barrier for easy removal yet adequate resistance to incidentaltouching during the dental procedure, and the composition will remainsufficiently in place against tissue during the procedure.

The method of making the polymerizable isolation barrier is carried outby providing at least one monomer; providing at least one curing agentfor curing the at least one monomer; and by providing at least one ofthree preferred additives that include the organic polymerizationstrength reducer, the tissue adherence accentuator, or the reflectivematerial. The ingredients are blended in a container until homogeneous,and the homogenous mixture is place in a container that is resistant tolight energy. The inventive polymerizable isolation barrier material ispreferably stored at or below room temperature. The inventivepolymerizable isolation barrier material is stable enough to be storedunder normal conditions at the operatory until activated by suitablelight radiant energy.

G. Methods of Use.

The inventive polymerizable isolation barrier material is made in apaste or gel form that is rheologically able to be expressed from adental syringe. The components of the isolation barrier material formeither an emulsion or a solution depending upon selection of a preferredapplication. The inventive polymerizable isolation barrier material isalso preferably made in a roll or tape form of a curable putty that isrolled onto the gums, pressed into place, for example with fingerpressure, carved to isolate hard tissue, and then cured with lightradiant energy. The components of this isolation barrier material formeither an emulsion, dispersion, suspension, solution, etc. dependingupon selection of a preferred application.

The inventive polymerizable isolation barrier material is applied by anyof several methods. FIG. 3 is an elevational oblique view of a patientduring installation of the inventive isolation barrier 28, in whichisolation barrier 28 is being expressed through a syringe 30substantially conformably to the tooth-gum interface 32 in preparationfor polymerization by light radiant energy. A preferred method of use isto dry the tooth or teeth that are to be treated, retract the labia, andapply the isolation barrier material 28 with syringe conformably at thebase of the tooth upon the tissue such as the gums 34. The width W ofisolation barrier 28 as it extends across tissue may be selected by theclinician according to the application. For example, where a gel isbeing used and running of the gel is not likely, the clinician may applya substantially conformal isolation barrier that touches the teeth andextends onto the gums 34 from about three to about 10 mm from the areato be treated. Larger or smaller isolation barriers may be applieddepending upon the specific dental procedure.

Removal of isolation barrier 28 after the dental treatment isaccomplished as illustrated in FIG. 4. A tweezers-like instrument 36 maybe used to remove isolation barrier 28 by taking hold of isolationbarrier 28 and removing it in discrete segments. It can be seen thatisolation barrier 28 is lifting away from gums 34 at the area near whereinstrument 36 has fastened onto isolation barrier 28. The clinician cantake hold of polymerized isolation barrier 28 with instrument 36 andremove it in discrete segments. The size of the discrete segments isgenerally about one-half the area that isolation barrier 28 isisolating. For example, when the whole arch is being isolated, it ispreferable that the discrete segments are about one-fourth the length ofthe arch, more preferably about one-half the length of the arch, andmost preferably, as illustrated in FIG. 4, isolation barrier 28 will beremoved as an integral unit.

EXAMPLES OF THE PREFERRED EMBODIMENTS

Several examples of the present invention are presented as merelyillustrative of some embodiments of the present invention. Theseexamples are not to be construed as limiting the spirit and scope of theinvention. The following nine hypothetical examples were produced infurtherance of reducing the present invention to practice. All amountsare given in weight percent.

EXAMPLE 1

    ______________________________________                                                           Percent by Weight                                          Component          of the Mixture                                             ______________________________________                                        mica                2.0                                                       xanthan gum         0.1                                                       curing agents       0.3                                                       cetyl alcohol      12.5                                                       precipitated silica                                                                              13.0                                                       triethylene glycol dimethacrylate                                                                72.1                                                       ______________________________________                                    

The foregoing example produces an isolation barrier material compositionthat, upon application to the dental substrate and polymerization, issufficiently weakened to facilitate its removal in discrete, tooth-sizedsegments or larger with a tweezers-like instrument from the dentalsubstrate after use in a dental procedure. The barrier material also isresistant to deformation at the external surface of the barrier due toincidental touching but remains adherent to the dental substrate at theinternal surface of the barrier. The barrier material also is configuredto decrease the polymerization reaction rate and to reflect excessivelight radiant energy to thereby resist thermal tissue damage due tosubstantial heat production during polymerization.

EXAMPLE 2

    ______________________________________                                                         Percent by Weight                                            Component        of the Mixture                                               ______________________________________                                        mica             3.0                                                          xanthan gum      0.3                                                          curing agents    0.5                                                          PEG dimethacrylate (300)                                                                       96.2                                                         ______________________________________                                    

The foregoing example produces an isolation barrier material compositionthat, upon application to the dental substrate and polymerization, isresistant to deformation at the external surface of the barrier due toincidental touching but remains adherent to the dental substrate at theinternal surface of the barrier. The barrier material also reflectsexcessive light radiant energy in order to resist thermal tissue damagedue to substantial heat production during polymerization.

EXAMPLE 3

    ______________________________________                                                          Percent by Weight                                           Component         of the Mixture                                              ______________________________________                                        titanium dioxide   1.0                                                        guar gum           0.1                                                        steryl alcohol    17.0                                                        precipitated silica                                                                             12.0                                                        2-hydroxy ethyl methacrylate                                                                    69.0                                                        curing agents      0.9                                                        ______________________________________                                    

The foregoing example produces an isolation barrier material compositionthat, upon application to the dental substrate and polymerization, issufficiently weakened to facilitate its removal in discrete, tooth-sizedsegments or larger with a tweezers-like instrument from the dentalsubstrate after use in a dental procedure The barrier material also isresistant lo deformation at the external surface of the barrier due toincidental touching but remains adherent to the dental substrate at theinternal surface of the barrier. The barrier material also is configuredto decrease the polymerization reaction rate and reflect excessive lightradiant energy to thereby resist thermal tissue damage due tosubstantial heat production during polymerization.

EXAMPLE 4

    ______________________________________                                                         Percent by Weight                                            Component        of the Mixture                                               ______________________________________                                        xanthan gum      1.0                                                          PEG dimethacrylate (600)                                                                       98.5                                                         curing agents    0.5                                                          ______________________________________                                    

The foregoing example produces an isolation barrier material compositionthat, upon application to the dental substrate and polymerization, isresistant to deformation at the external surface of the barrier due toincidental touching but remains adherent to the dental substrate at theinternal surface of the barrier.

EXAMPLE 5

    ______________________________________                                                           Percent by Weight                                          Component          of the Mixture                                             ______________________________________                                        cetyl alcohol      20.0                                                       tri ethylene glycol dimethacrylate                                                               79.0                                                       curing agents       1.0                                                       ______________________________________                                    

The foregoing example produces an isolation barrier material compositionthat, upon application to the dental substrate and polymerization, issufficiently weakened to facilitate its removal in discrete, tooth-sizedsegments or larger with a tweezers-like instrument from the dentalsubstrate after use in a dental procedure.

EXAMPLE 6

    ______________________________________                                                         Percent by Weight                                            Component        of the Mixture                                               ______________________________________                                        titanium dioxide 1.0                                                          mica             5.0                                                          urethane dimethacrylate                                                                        93.8                                                         curing agents    0.2                                                          ______________________________________                                    

The foregoing example produces an isolation barrier material compositionthat, upon application to the dental substrate and polymerization,reflects excessive light radiant energy in order to resist thermaltissue damage due to substantial heat production during polymerization.

EXAMPLE 7

    ______________________________________                                                           Percent by Weight                                          Component          of the Mixture                                             ______________________________________                                        xanthan gum         0.2                                                       cetyl alcohol      12.0                                                       curing agents       0.5                                                       tri ethylene glycol dimethacrylate                                                               87.3                                                       ______________________________________                                    

The foregoing example produces an isolation barrier material compositionthat, upon application to the dental substrate and polymerization, issufficiently weakened to facilitate its removal in discrete, tooth-sizedsegments or larger with a tweezers-like instrument from the dentalsubstrate after use in a dental procedure. The barrier material also isresistant to deformation at the external surface of the barrier due toincidental touching but remains adherent to the dental substrate at theinternal surface of the barrier. The barrier material is also configuredto decrease the polymerization reaction rate and thereby resist thermaltissue damage due to substantial heat production during polymerization.

EXAMPLE 8

    ______________________________________                                                         Percent by Weight                                            Component        of the Mixture                                               ______________________________________                                        aluminum oxide   1.0                                                          xanthan gum      2.0                                                          curing agents    0.5                                                          glycerol dimethacrylate                                                                        96.5                                                         ______________________________________                                    

The foregoing example produces an isolation barrier material compositionthat, upon application to the dental substrate and polymerization,remains adherent to the dental substrate at the internal surface of thebarrier. The barrier material also is configured to decrease thepolymerization reaction rate and thereby resist thermal tissue damagedue to substantial heat production during polymerization.

EXAMPLE 9

    ______________________________________                                                         Percent by Weight                                            Component        of the Mixture                                               ______________________________________                                        cetyl alcohol    12.0                                                         aluminum flake    3.0                                                         butane di-ol dimethacrylate                                                                    84.5                                                         curing agents     0.5                                                         ______________________________________                                    

The foregoing example produces an isolation barrier material compositionthat, upon application to the dental substrate and polymerization, issufficiently weakened to facilitate its removal in discrete, tooth-sizedsegments or larger with a tweezers-like instrument from the dentalsubstrate after use in a dental procedure. The barrier material also isconfigured to decrease the polymerization reaction rate and reflectexcessive light radiant energy to thereby resist thermal tissue damagedue to substantial heat production during polymerization.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrated andnot restrictive. The scope of the invention is, therefore, indicated bythe appended claims and their combination in whole or in part ratherthan by the foregoing description. All changes that come with in themeaning and range of equivalency of the claims are to be embraced withintheir scope.

What is claimed and desired to be secured by United States LettersPatent is:
 1. A polymerizable isolation barrier for isolating a dentalsubstrate to confine a dental treatment composition to an area definedby the isolation barrier, the polymerizable isolation barrier comprisingthe mixture products of:at least one monomer; at least one curing agentfor curing the at least one monomer; and at least one tissue adherenceaccentuator.
 2. A polymerizable isolation barrier according to claim 1,wherein the at least one monomer is selected from the group consistingof triethylene glycol dimethacrylate, polyethylene glycoldimethacrylate, butane di-ol dimethacrylate, 2-hydroxy ethylmethacrylate, glycerol dimethacrylate, bis-GMA, and urethanedimethacrylate.
 3. A polymerizable isolation barrier according to claim1, wherein the at least one monomer is in a concentration range fromabout 50 to about 99 percent by weight of the barrier.
 4. Apolymerizable isolation barrier according to claim 1, wherein the atleast one monomer is selected from the group consisting ofalkylmethacrylates, alkylhydroxymethacrylates, andalkylaminomethacrylates.
 5. A polymerizable isolation barrier accordingto claim 1, wherein the at least one tissue adherence accentuator is agum.
 6. A polymerizable isolation barrier according to claim 1, whereinthe at least one tissue adherence accentuator is a gum selected from thegroup consisting of xanthan gum, guar gum, and tragacanth gum.
 7. Apolymerizable isolation barrier according to claim 1, wherein the atleast one tissue adherence accentuator is a cellulose material.
 8. Apolymerizable isolation barrier according to claim 1, wherein the atleast one tissue adherence accentuator is a cellulose material selectedfrom the group consisting of ethyl cellulose, and hydroxypropyl methylcellulose.
 9. A polymerizable isolation barrier according to claim 1,wherein the at least one tissue adherence accentuator is a highmolecular weight polyol.
 10. A polymerizable isolation barrier accordingto claim 1, wherein the at least one tissue adherence accentuator is apolyol having high molecular weight of at least about 600 and whereinthe polyol is selected from group consisting of polyethylene glycol andpolypropylene glycol.
 11. A polymerizable isolation barrier according toclaim 1, wherein the at least one tissue adherence accentuator is apolymer selected from the group consisting of polysiloxanes, carboxypoly methylene and water-soluble polyethylene oxides.
 12. Apolymerizable isolation barrier according to claim 1, wherein the atleast one tissue adherence accentuator is in a concentration range fromabout 0.01 percent to about 9 percent by weight of the barrier.
 13. Apolymerizable isolation barrier according to claim 1, wherein the atleast one tissue adherence accentuator is in sufficient concentration toadhere to the dental substrate at a surface of the isolation barrierinterfacing with the dental substrate during a dental procedure.
 14. Apolymerizable isolation barrier according to claim 1, further comprisingan organic polymerization strength reducer.
 15. A polymerizableisolation barrier according to claim 14, wherein the organicpolymerization strength reducer is an alcohol.
 16. A polymerizableisolation barrier according to claim 14, wherein the organicpolymerization strength reducer is cetyl alcohol.
 17. A polymerizableisolation barrier according to claim 14, wherein the organicpolymerization strength reducer is steryl alcohol.
 18. A polymerizableisolation barrier according to claim 14, wherein the organicpolymerization strength reducer is a polyol.
 19. A polymerizableisolation barrier according to claim 14, wherein the organicpolymerization strength reducer is a polyol selected from the groupconsisting of polyethylene glycols, polypropylene glycols, and propyleneglycol.
 20. A polymerizable isolation barrier according to claim 14,wherein the organic polymerization strength reducer is an oil.
 21. Apolymerizable isolation barrier according to claim 14, wherein theorganic polymerization strength reducer is a mineral oil.
 22. Apolymerizable isolation barrier according to claim 14, wherein theorganic polymerization strength reducer is in a concentration range fromabout 1 to about 30 percent by weight of the barrier.
 23. Apolymerizable isolation barrier according to claim 14, wherein theorganic polymerization strength reducer is in sufficient concentrationto lower the ability of the monomer to polymerize.
 24. A polymerizableisolation barrier according to claim 14, wherein the at least oneorganic polymerization strength reducer is in sufficient concentrationto facilitate removal of the barrier from the dental substrate by handor by a dental tool.
 25. A polymerizable isolation barrier according toclaim 1, further comprising at least one reflective material forreflecting light radiant energy.
 26. A polymerizable isolation barrieraccording to claim 25, wherein the at least one reflective material is ametal.
 27. A polymerizable isolation barrier according to claim 25,wherein the at least one reflective material is a metal selected fromthe group consisting of gold flake, aluminum flake and titanium flake.28. A polymerizable isolation barrier according to claim 25, wherein theat least one reflective material is a metal oxide.
 29. A polymerizableisolation barrier according to claim 25, wherein the at least onereflective material is a metal oxide selected from the group consistingof aluminum oxide, titanium dioxide, precipitated silica, ceria, andthoria.
 30. A polymerizable isolation barrier according to claim 25,wherein the at least one reflective material is a mica.
 31. Apolymerizable isolation barrier according to claim 25, wherein the atleast one reflective material is provided in a concentration range fromabout 1 to about 50 percent by weight of the barrier.
 32. Apolymerizable isolation barrier according to claim 25, wherein the atleast one reflective material is in sufficient concentration to decreasea polymerization reaction rate compared to a polymerization reactionrate of the isolation barrier material without a reflective material.33. A polymerizable isolation barrier according to claim 25, wherein theat least one reflective material is in sufficient concentration toprevent substantial thermal tissue damage during a polymerization of theisolation barrier.
 34. A polymerizable isolation barrier for isolating adental substrate to confine a dental treatment composition to an areadefined by the isolation barrier, the polymerizable isolation barriercomprising the mixture products of:at least one monomer; at least onecuring agent for curing the at least one monomer; and at least onetissue adherence accentuator selected from the group consisting of agum, a cellulose material, a high molecular weight polyol and a polymer.35. A polymerizable isolation barrier according to claim 34, wherein theat least one monomer is selected from the group consisting ofalkylmethacrylates, alkylhydroxymethacrylates, andalkylaminomethacrylates.
 36. A polymerizable isolation barrier accordingto claim 34, wherein the gum is selected from the group consisting ofxanthan gun, guar gum, and tragacanth gum.
 37. A polymerizable isolationbarrier according to claim 34, wherein the cellulose material isselected from the group consisting of ethyl cellulose, and hydroxypropylmethyl cellulose.
 38. A polymerizable isolation barrier according toclaim 34, wherein the polyol has a molecular weight of at least about600 and is selected from group consisting of polyethylene glycol andpolypropylene glycol.
 39. A polymerizable isolation barrier according toclaim 34, wherein the polymer is selected from the group consisting ofpolysiloxanes, carboxy poly methylene and water-soluble polyethyleneoxides.
 40. A polymerizable isolation barrier according to claim 34,wherein the at least one tissue adherence accentuator is in aconcentration range from about 0.01 percent to about 9 percent by weightof the barrier.
 41. A polymerizable isolation barrier according to claim34, wherein the at least one tissue adherence accentuator is insufficient concentration to adhere to the dental substrate at a surfaceof the isolation barrier interfacing with the dental substrate during adental procedure.
 42. A polymerizable isolation barrier according toclaim 34, further comprising an organic polymerization strength reducer.43. A polymerizable isolation barrier according to claim 34, furthercomprising at least one reflective material for reflecting light radiantenergy.
 44. A polymerizable isolation barrier for isolating a dentalsubstrate to confine a dental treatment composition to an area definedby the isolation barrier, the polymerizable isolation barrier comprisingthe mixture products of:at least one monomer; at least one curing agentfor curing the at least one monomer; and at least one tissue adherenceaccentuator selected from the group consisting of xanthan gum, guar gum,tragacanth gum, ethyl cellulose, hydroxypropyl methyl cellulose,polyethylene glycol with a molecular weight of at least about 600,polypropylene glycol with a molecular weight of at least about 600,polysiloxanes, carboxy poly methylene and water-soluble polyethyleneoxides.
 45. A polymerizable isolation barrier according to claim 44,wherein the at least one monomer is selected from the group consistingof alkylmethacrylales, alkylhydroxymethacrylates, andalkylaminomethlcrylates.
 46. A polymerizable isolation barrier accordingto claim 44, wherein the at least one tissue adherence accentuator is ina concentration range from about 0.01 percent to about 9 percent byweight of the barrier.
 47. A polymerizable isolation barrier accordingto claim 44, wherein the at least one tissue adherence accentuator is insufficient concentration to adhere to the dental substrate at a surfaceof the isolation barrier interfacing with the dental substrate during adental procedure.
 48. A polymerizable isolation barrier according toclaim 44, further comprising an organic polymerization strength reducer.49. A polymerizable isolation barrier according to claim 44, furthercomprising at least one reflective material for reflecting light radiantenergy.
 50. A method of making a polymerizable isolation barrier forisolating a dental substrate to confine a dental treatment compositionto an area defined by the isolation barrier, the polymerizable isolationbarrier comprising mixing together at least one monomer, at least onecuring agent for curing the at least one monomer, and at least onetissue adherence accentuator.